A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

This study has been completed.

Sponsor:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00990912

First Posted: October 7, 2009

Last Update Posted: February 5, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.

A Study to Document Long-term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects 1 - 21 Years of Age With Refractory Solid Tumors Who Have Experienced Clinical Benefit Following a Minimum of 6 Cycles of Therapy on BMS Protocol CA124-001 or BMS Protocol CA124-002

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

1 Year to 18 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy

Karnofsky score of at least 50 for subjects > 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger

Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies

Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002

Exclusion Criteria:

A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy

Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study